Bridgewater, New jersey
Project Manager - US POC Job Opening in Bridgewater, New jersey - Working as part of the Genpact Pharmalink team gives you a career that will be varied, diverse and never dull! You will be joining a team of the best Regulatory Affairs Professionals in the industry, some of the most experienced and progressive minds. Our consultants come from a wide spectrum within the Healthcare Industry, all bringing invaluable skills and attributes that allow us to provide the best Regulatory Affairs expertise to our clients. Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients? needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants, which will allow us to continue to provide the level of service our clients have come to expect from Genpact Pharmalink. The success of Genpact Pharmalink depends on its people. Capitalizing on what is unique about individuals and drawing on their different perspectives and experiences will add value to the way we do business. By accessing, recruiting and developing talent from the widest possible talent pool we can gain an insight into different markets and generate greater creativity in anticipating employee and client needs.
JOB SUMMARY:
This position is part of the US Quality & Compliance organization responsible for managing Product Technical Complaint handling. The Project Manager oversees the operational management of and provides leadership to Specialists, Analysts and Technicians within the US PQC department as well as assists in setting daily priorities within the PTC work flow. Knowledge of regulatory requirements, quality & compliance and complaint handling is required. Experience in project management of staff and department activities is required.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Manages daily activities of Product Quality Complaints department
Understands all drug, device, combination products and biologics complaint activity and corresponding Analyst and Technician job functions throughout the US PQC and FAR departments
Managing all positions within US PQC and FAR contractor Group
Responsible for ensuring department complies with FDA regulations, company standards, and department SOPs surrounding the daily technical complaint processing
Performs QC Checks on complaint cases
Identifies complaints for Field Alert Reporting
Ensures department meets cGMP training guidelines
Regularly monitors all PQC activities for quality and completeness
Maintains and monitors data consistency and completeness within the Siebel and PTC databases
Monitors and tracks case assignment on a daily basis
Monitors department issues and implements necessary follow-up
Participate in both short and long-term strategy within department
Prepares and distributes dashboards reports listing monthly complaint activity.
Prepares and reviews trending data, identifies areas of concern, and notifies responsible management and manufacturing sites.
Provides feedback on both personnel and product issues to PQC Management
Understands the global quality standards for product technical complaints.
Acts as lead trainer for new associates
Acts as subject matter expert on all products handled by US PQC and FAR
Responsible for assisting PQC Managers with PQC Technical Complaints as needed
Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.
Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
Performs other duties as assigned.
Desired Education:
Bachelor's degree required. Science, engineering or related field (advanced degree preferred)
Desired Experience:
Minimum of 5 to 7 years of related experience within the pharmaceutical industry.
Strong Verbal and Written Communication Skills
Problem Solving Skills
Good organizational skills
Strong Leadership skills
Analytical skills
Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics
Project and Time Management Skills
Ability to multitask in a highly stressful environment
Ability to operate in a constantly changing environment
General understanding of statistics
Please provide current and desired salary requirements, along with your resume.
Job Type: Full-time
Job Location:
Bridgewater, NJ
Required education:
Bachelor's
Required experience:
Project Management: 5 years
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